PRECLINICAL VALIDATION OF FIRST IN MAN ENDOVASCULAR BRAIN MACHINE INTERFACE DEVICE

Abstract

The stentrode technology has been given significant public attention, following publication in the fourth highest impact factor journal 'Nature Biotechnology' and a public statement of endorsement by the President of the United States in 2016. The program now seeks to conduct a preclinical validation program to satisfy the FDA in its requirements to provide Investigational Device Exemption (IDE).